Strength and Muscle Related Outcomes for Nutrition and Lung Function in CF

Launched by JAEB CENTER FOR HEALTH RESEARCH · Nov 28, 2022

Keywords

ClinConnect Summary

This clinical trial is looking into how nutrition and body composition affect lung function in adults with cystic fibrosis (CF). The researchers want to understand different ways to measure body health and strength in people with CF, comparing these methods to a well-known tool called DXA, which helps assess body composition. The study will also explore how psychological factors and other health issues contribute to nutritional challenges in adults with advanced lung disease. By gathering this information, the researchers aim to improve future nutritional interventions for individuals with CF.

To be eligible for the trial, participants must be adults aged 18 and older, with lung function measured by a test called FEV1. Depending on their lung function, they will be placed in one of two groups: those with lower lung function (60% or less) and those with better lung function (60% or more). It's important that participants haven't had any recent major medical treatments, like organ transplants or new medications for weight loss, that could affect the study results. If you decide to join, you can expect to undergo various assessments related to nutrition and body health, which will help us better understand how to support people living with cystic fibrosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Cohort 1: Patients are eligible if their percentage of predicated forced expiratory volume in1 second (FEV1) is 60% or lower at screening.
• • Cohort 2: Patients are eligible if their percentage of predicted forced expiratory volume in 1 second (FEV1) is 60% or greater at screening.
• • Both cohorts match by age, gender, race and CFTR genotype severity.
• Exclusion Criteria:
• • No prior solid organ transplantation
• • No initiation of an investigation drug within 28 days prior to and including Visit 1
• • No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston, CFTR modulator) within 28 days prior to and including Visit 1.
• • No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 14 days prior to and including Visit 1.
• • For the BIA sub-study - Individuals with an implanted pacemaker will be excluded.
• • No initiation of a drug for weight loss (such as a GLP-1 receptor agonist) or bariatric surgery within 6-months prior to and including the Baseline visit.
• • Patients with continued rapid change or extreme GI symptoms related to weight loss therapy should be excluded at the discretion of the study investigator.

Trial Officials